HealthyPhase 1NCT06518122

A Study to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers

A Phase 1 study testing HCP1306, RLD2302 and RLD2102 in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the drug-drug interaction and safety between HCP1306, RLD2302 and RLD2102 in healthy volunteers. Read more about this study

Who is it for?: Ages 19 to 54 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: HCP1306, RLD2302 and RLD2102
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteSouth Korea
Study dates: 1 Sep 2024to 3 Jan 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 54 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age 19~54 years in healthy volunteers
18.5 kg/m^2 ≤ BMI < 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 mmHg
Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug
Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Who cannot join

Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
Subjects who judged ineligible by the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Jeonbuk National University Hospital
Jeonju, Jeollabuk-do

Other trials in South Korea

About this study

Official title: A Randomized, Open Label, Multiple Dose, Crossover Clinical Trial to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers

The purpose of this study is to evaluate the drug-drug interaction and safety between HCP1306, RLD2302 and RLD2102 in healthy volunteers.

Read the detailed description

[PART A] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302

[PART B] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302, RLD2102

Conditions: Healthy
Being tested: HCP1306, RLD2302, RLD2102

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HCP1306Drug
Take it once a day per period.
RLD2302Drug
Take it once a day per period.
RLD2102Drug
Take it once a day per period

Study groups in NCT06518122
Study group	Role	What they receive
[PART A] Sequence 1	Experimental	Period1 : Treatment A (HCP1306) Period2 : Treatment B (RLD2302) Period3 : Treatment C (HCP1306+RLD2302) Receives: Drug: HCP1306; Drug: RLD2302
[PART A] Sequence 2	Experimental	Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment B (RLD2302) Receives: Drug: HCP1306; Drug: RLD2302
[PART A] Sequence 3	Experimental	Period1 : Treatment B (RLD2302) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment A (HCP1306) Receives: Drug: HCP1306; Drug: RLD2302
[PART A] Sequence 4	Experimental	Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment B (RLD2302) Period3 : Treatment A (HCP1306) Receives: Drug: HCP1306; Drug: RLD2302
[PART A] Sequence 5	Experimental	Period1 : Treatment B (RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment C (HCP1306+RLD2302) Receives: Drug: HCP1306; Drug: RLD2302
[PART A] Sequence 6	Experimental	Period1 : Treatment A (HCP1306) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment B (RLD2302) Receives: Drug: HCP1306; Drug: RLD2302
[PART B] Single arm	Experimental	Period1 : Treatment D (RLD2102) Period2 : Treatment C (HCP1306) Period3 : Treatment E (HCP1306, RLD2302, RLD2102) Receives: Drug: HCP1306; Drug: RLD2302; Drug: RLD2102

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCtau
Pharmacokinetic evaluation
Measured: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Css,max
Pharmacokinetic evaluation
Measured: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

Secondary outcomes (8)

Css,min
Pharmacokinetic evaluation
Measured: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Css,av
Pharmacokinetic evaluation
Measured: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Tss,max
Pharmacokinetic evaluation
Measured: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
t1/2
Pharmacokinetic evaluation
Measured: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
CLss/F
Pharmacokinetic evaluation
Measured: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Vdss/F
Pharmacokinetic evaluation
Measured: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Fluctuation[(Css,max-Css,min)/Css,av]
Pharmacokinetic evaluation
Measured: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Swing[(Css,max-Css,min)/Css,min]
Pharmacokinetic evaluation
Measured: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20243 Jan 2025

First posted24 Jul 2024
Study start1 Sep 2024
Primary completion3 Jan 2025
Study completion3 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: \[PART A\] 6 x 3 Crossover \[PART B\] Single Arm (Three periods)
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06518122
Sponsor's protocol ID: HM-ROEM-101
Status last verified: Feb 2025
First submitted: 18 Jul 2024
Last updated: 20 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open Label, Multiple Dose, Crossover Clinical Trial to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers
ClinicalTrials.gov ID: NCT06518122
Acronym / sponsor ID: HM-ROEM-101
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
Study start: 1 Sep 2024 (actual)
Primary completion: 3 Jan 2025 (actual)
Study completion: 3 Jan 2025 (actual)
First posted: 24 Jul 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the drug-drug interaction and safety between HCP1306, RLD2302 and RLD2102 in healthy volunteers.

Detailed description

[PART A] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302

[PART B] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302, RLD2102

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 7
Model description: [PART A] 6 x 3 Crossover [PART B] Single Arm (Three periods)

Arm	Type	Receives
[PART A] Sequence 1	Experimental	Drug: HCP1306, Drug: RLD2302Period1 : Treatment A (HCP1306) Period2 : Treatment B (RLD2302) Period3 : Treatment C (HCP1306+RLD2302)
[PART A] Sequence 2	Experimental	Drug: HCP1306, Drug: RLD2302Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment B (RLD2302)
[PART A] Sequence 3	Experimental	Drug: HCP1306, Drug: RLD2302Period1 : Treatment B (RLD2302) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment A (HCP1306)
[PART A] Sequence 4	Experimental	Drug: HCP1306, Drug: RLD2302Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment B (RLD2302) Period3 : Treatment A (HCP1306)
[PART A] Sequence 5	Experimental	Drug: HCP1306, Drug: RLD2302Period1 : Treatment B (RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment C (HCP1306+RLD2302)
[PART A] Sequence 6	Experimental	Drug: HCP1306, Drug: RLD2302Period1 : Treatment A (HCP1306) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment B (RLD2302)
[PART B] Single arm	Experimental	Drug: HCP1306, Drug: RLD2302, Drug: RLD2102Period1 : Treatment D (RLD2102) Period2 : Treatment C (HCP1306) Period3 : Treatment E (HCP1306, RLD2302, RLD2102)

Who may qualify

Ages: 19 to 54 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Age 19~54 years in healthy volunteers
18.5 kg/m^2 ≤ BMI < 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 mmHg
Agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug
Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Key exclusion criteria (2 listed)

Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
Subjects who judged ineligible by the investigator

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HCP1306Take it once a day per period.	Drug	[PART A] Sequence 1, [PART A] Sequence 2, [PART A] Sequence 3, [PART A] Sequence 4, [PART A] Sequence 5, [PART A] Sequence 6, [PART B] Single arm
RLD2302Take it once a day per period.	Drug	[PART A] Sequence 1, [PART A] Sequence 2, [PART A] Sequence 3, [PART A] Sequence 4, [PART A] Sequence 5, [PART A] Sequence 6, [PART B] Single arm
RLD2102Take it once a day per period	Drug	[PART B] Single arm

Primary outcome

AUCtau
Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Pharmacokinetic evaluation
Css,max
Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Pharmacokinetic evaluation

8 secondary outcomes

Css,min
Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Css,av
Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Tss,max
Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
t1/2
Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
CLss/F
Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Vdss/F
Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Fluctuation[(Css,max-Css,min)/Css,av]
Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Swing[(Css,max-Css,min)/Css,min]
Time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Min-gul Kim, MD principal investigator

Jeonbuk National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HCP1306, RLD2302 and RLD2102 in people with Healthy, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCtau (time frame: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06518122.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.